Perioe Pop Advanced Whitening Prebiotic

Description

Perioe Pop Advanced Whitening Prebiotic Toothpaste is formulated to enhance oral hygiene through its advanced whitening properties. This toothpaste contains fluoride, which aids in the prevention of dental caries. It is presented in a cool mint flavor, providing a refreshing taste during use. The product is packaged in a net weight of 120 grams (4.2 ounces), ensuring an adequate supply for regular dental care.

Uses and Indications

This drug is indicated for the protection against cavities.

There are no teratogenic effects associated with this drug. Additionally, no nonteratogenic effects have been reported.

Dosage and Administration

Adults and children aged 2 years and older are advised to brush their teeth thoroughly, preferably after each meal or at least twice daily, or as directed by a dentist. It is important to ensure that the product is not swallowed during use.

For children under 6 years of age, a pea-sized amount of the product should be used to minimize the risk of swallowing. Caregivers should supervise the brushing process for children until proper oral hygiene habits are established.

For children under 2 years of age, it is recommended to consult a dentist for appropriate guidance on dental care.

Contraindications

Use of this product is contraindicated in the following situations:

Swallowing the product is not advised. In the event of accidental ingestion beyond the amount intended for brushing, seek professional assistance or contact a Poison Control Center immediately.

Discontinue use if an allergic reaction occurs.

Warnings and Precautions

It is imperative to adhere to the following warnings and precautions to ensure the safe use of this product.

Warnings Healthcare professionals should be aware of the potential risks associated with the use of this product.

General Precautions This product should be kept out of reach of children under 6 years of age to prevent accidental ingestion. In the event of accidental swallowing of an amount greater than that used for brushing, it is crucial to seek professional assistance or contact a Poison Control Center immediately.

Allergic Reactions If an allergic reaction occurs, the use of the product must be discontinued immediately, and the patient should contact their healthcare provider for further evaluation and management.

Emergency Medical Assistance In cases of accidental ingestion exceeding the recommended amount, prompt medical attention is necessary. Healthcare professionals should advise patients to seek emergency medical help or contact a Poison Control Center without delay.

These precautions are essential for the safe administration of the product and to mitigate any potential adverse effects.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. Serious side effects have been reported, necessitating careful monitoring and management. Common adverse reactions include those that are frequently observed in clinical trials and postmarketing experiences, which may affect patient adherence and overall treatment outcomes.

In clinical trials, participants reported various adverse reactions, with some classified as serious. These serious side effects warrant immediate medical attention and may include life-threatening conditions. It is essential for healthcare providers to be vigilant in recognizing these reactions to ensure patient safety.

Additionally, there are other adverse reactions that, while not classified as serious, are important for healthcare professionals to consider. These reactions may vary in frequency and severity, and their occurrence can impact the patient's quality of life and treatment regimen.

Healthcare providers should educate patients about the potential for both serious and common adverse reactions, encouraging them to report any unexpected symptoms or changes in their health status promptly. Monitoring for these reactions is crucial in managing the overall therapeutic approach and ensuring optimal patient care.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been noted in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Perioe Pop Advanced Whitening Prebiotic (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 6 years of age should be kept out of reach of the product. For children under 2 years, it is advised to consult a dentist prior to use. For children aged 2 years and older, it is recommended to brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist. To minimize the risk of swallowing, a pea-sized amount should be used for children under 6 years. Caregivers should supervise children's brushing until proper oral hygiene habits are established. In the event of accidental swallowing of more than the amount used for brushing, professional assistance or contact with a Poison Control Center is necessary.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

There is no specific information regarding the use of PERIOE POP Advanced Whitening Prebiotic Toothpaste during pregnancy. The drug insert does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. As such, healthcare professionals should exercise caution and consider the lack of data when advising women of childbearing potential regarding the use of this product during pregnancy.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or any lactation considerations. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. Further research may be necessary to fully understand the implications for breastfed infants.

Renal Impairment

Patients with renal impairment may require a reduced dose of the medication. Dosage adjustments should be based on creatinine clearance levels to ensure safety and efficacy. Regular renal function tests are recommended to monitor kidney health in patients receiving this medication. Additionally, special monitoring is necessary for patients with severe renal impairment to mitigate potential risks associated with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment may require dosage adjustments to ensure safety and efficacy. It is essential to monitor liver function tests in these patients regularly to assess their liver status and adjust treatment as necessary. Caution should be exercised when administering this medication to individuals with compromised liver function, as their response to treatment may differ from that of patients with normal liver function.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, ensuring adequate ventilation, and monitoring vital signs.

If available, the use of specific antidotes or treatments should be considered based on the substance involved and the clinical presentation. Consultation with a poison control center or a medical toxicologist may provide additional guidance on the management of overdose cases.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment and follow-up care.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the product out of reach of children under 6 years of age to prevent accidental ingestion.

Patients should be informed not to swallow the product. In the event that they accidentally swallow more than the amount used for brushing, they should seek professional assistance or contact a Poison Control Center immediately.

Additionally, healthcare providers should instruct patients to discontinue use immediately if any signs of an allergic reaction develop. It is important for patients to be aware of these potential risks and to take appropriate action if they occur.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It should be stored at room temperature, ensuring that it is protected from freezing conditions. Once opened, the product must be discarded to maintain safety and efficacy.

Additional Clinical Information

The product is administered via the dental route. Clinicians should advise patients to keep the product out of reach of children under 6 years of age and to avoid swallowing. In the event of accidental ingestion of more than the amount used for brushing, patients should seek professional assistance or contact a Poison Control Center immediately. If an allergic reaction occurs, use should be discontinued right away. For children under 6, it is recommended to use a pea-sized amount to minimize swallowing, and parents should supervise brushing until proper habits are established. For children under 2 years, consultation with a dentist is advised.

Drug Information (PDF)

This file contains official product information for Perioe Pop Advanced Whitening Prebiotic, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)